Kornimate/medical-research-clean huggingface dataset:
impact of psychological therapies on emergency medical patients

Conditions: Mental Health Disorder; Mental Disorder; Mental Health Wellness 1

Summary: prevalence of anxiety and depression in the general population is known, but is under researched in the acute hospital setting and there is little evidence on the prevalence of anxiety and depression within the emergency medical admission population. a potential intervention for treating such mental health prevalence would be in the form of iapt methodology which has been utilised in other parts of the nhs demonstrating good outcomes. therefore, this feasibility study will explore the utility of iapt in the acute setting. this study will explore the prevalence of anxiety and depression in the emergency medical population within medical inpatient wards , utilising the assessment tools adopted by the iapt services and explained in detail below. the study will explore a) feasibility of introducing psychological intervention to an emergency medical ward and b) provide preliminary data on the outcome of this intervention on hospital length of stay and readmission rates.


Eligibility criteria:
inclusion criteria: * patients admitted to ipswich hospital into a ward that cares for patients who are medical emergencies. * patients who score 3 or higher on one or both of the gad 2 and phq 2. * patients that have capacity to consent. * over 18 years old. * ability to speak and read in english as the study will not have the resources to employ interpreters or to get documentation translated. * participants that are not deemed suicidal via screening and medical and nurse assessment. exclusion criteria: * patients not receiving care on a ward caring for medical emergencies. * patients under the age of 18 years old. * patients scoring \< 3 on both gad 2 and phq 2. * patients who do not have capacity to consent. * participants that are suicidal as via screening and medical and nurse assessment.
entospletinib in combination with idelalisib in adults with relapsed or refractory hematologic malignancies

Conditions: Chronic Lymphocytic Leukemia; Mantle Cell Lymphoma; Diffuse Large B-cell Lymphoma; Indolent Non-Hodgkin's Lymphoma

Summary: this study will evaluate the efficacy of the combination entospletinib and idelalisib in participants with relapsed or refractory hematologic malignancies. participants will be enrolled who have one of the following hematological tumor types: chronic lymphocytic leukemia (cll), mantle cell lymphoma (mcl), diffuse large b-cell lymphoma (dlbcl), or indolent non-hodgkin lymphomas (inhl; including follicular lymphoma (fl) and lymphoplasmacytoid lymphoma/waldenström macroglobulinemia \[lpl/wm\], small lymphocytic lymphoma \[sll\], or marginal zone lymphoma \[mzl\]).


Eligibility criteria:
key inclusion criteria: * diagnosis of b-cell indolent non-hodgkin lymphoma (inhl),diffuse large b-cell lymphoma (dlbcl),mantle cell lymphoma (mcl), or chronic lymphocytic leukemia (cll) as documented by medical records and with histology based on criteria established by the world health organization * for institutions that have phase 3 or phase 4 protocols studying idelalisib (zydelig®; gs-1101); individuals with malignancies being studied in these protocols must have failed screening and be registered as a screen failure in the respective idelalisib protocol * prior treatment for lymphoid malignancy * presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy * discontinuation of all therapy for the treatment of cancer ≥ 3 weeks before the start of study drug * all acute toxic effects of any prior antitumor therapy resolved to grade ≤ 1 before the start of study drug * karnofsky performance status of ≥ 60 * life expectancy of at least 3 months key exclusion criteria: * known histological transformation from inhl or cll to an aggressive form of nhl (ie, richter transformation) * known active central nervous system or leptomeningeal lymphoma * presence of known intermediate- or high-grade myelodysplastic syndrome * current therapy with agents that reduce gastric acidity, including but not limited to antacids, h2 inhibitors, and proton pump inhibitors * evidence of ongoing systemic bacterial, fungal, or viral infection at the time of start of study drug * ongoing liver injury * ongoing or recent hepatic encephalopathy * ongoing drug-induced pneumonitis * ongoing inflammatory bowel disease * ongoing alcohol or drug addiction * pregnancy or breastfeeding * history of prior allogeneic bone marrow progenitor cell or solid organ transplantation * ongoing immunosuppressive therapy * concurrent participation in an investigational drug trial with therapeutic intent note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: gs-us-339-0103 syk inhibitor pi3k inhibitor gs-9973 gs 9973 gs-1101 gs 1101 cal-101 cal 101 idelalisib leukemia lymphoma cll mcl dlbcl inhl fl mzl lpl sll wm waldenström's macroglobulinemia
the effects of eccentric compared to standard strength training in primary spinal cord injury rehabilitation

Conditions: Spinal Cord Injury

Summary: the goal of this clinical trial is to assess the effects of eccentric arm-crank (kreha) training compared to standard clinical routine strength (stan) training in individuals undergoing primary spinal cord injury (sci) rehabilitation. the main questions this trail aims to answer are: * what are the effects of the training on upper body strength, aerobic performance, muscle volume, functional independence, and health-related quality of life? * is the kreha training feasible to implement into the rehabilitation routine? participants will: * perform either 20 kreha sessions or 20 stan sessions within 12 weeks * perform a test battery to collect data on training effects before (pretest) and after (posttest) the study intervention


Eligibility criteria:
inclusion criteria: * 18 years or older. * informed consent as confirmed per signature. * traumatic or disease-related sci. * participating in the routine strength training program during primary sci rehabilitation at the study center (generally this is initiated around one month after sci onset). * wheelchair dependency during activities of daily living, defined by a score of 0-2 in the scim subsection regarding "mobility in the house". * passed sports medical assessment and having sufficient biceps/triceps function to perform arm-crank training, as determined by an experienced sports medicine physician exclusion criteria: * inflammatory or neurodegenerative diseases (including multiple sclerosis or guillain-barré syndrome). * comorbidities or other health issues that may interfere with study participation, inability or contraindications to undergo the investigated intervention. * mri contraindications (magnetic metal parts or electronic implants such as pacemakers in the body). * pregnancy (anamnestic).

Keywords: eccentric training strength training upper body aerobic performance muscle volume
evaluating the effectiveness of various iron salts in oral iron therapy for iron deficiency and anemia in healthy adults

Conditions: Iron Deficiency; Iron Deficiency Anemia

Summary: oral iron supplements are a cornerstone therapy for treating iron deficiency and iron deficiency anemia, aiming to replenish low iron levels in the body. these supplements typically contain various iron salts, such as ferrous sulfate, ferric maltol, ferrous gluconate, and ferric pyrophosphate. advancements in carrier systems, such as microencapsulation or complexation can enhance the absorption and bioavailability of iron supplements. by improving absorption, these carrier systems may mitigate gastrointestinal side effects and increase the efficacy of iron therapy.

this multicenter, randomized, double-blind parallel-group, clinical trial study aims to conduct a comparative analysis of the effectiveness of oral ferric maltose, vs sucrosomial iron. the study seeks to evaluate their efficacy in treating iron deficiency or iron deficiency anemia, two prevalent conditions associated with low iron levels in the body. this research aims to provide valuable insights into potential difference in these two iron supplement formulations, both in terms of relative effectiveness and potential gi side effects. this comparative analysis may guide healthcare providers in selecting the most suitable oral iron supplement based on individual patient characteristics, ultimately optimizing treatment outcomes and improving patient care.

Eligibility criteria:
inclusion criteria: * healthy adults aged 18-65 years * iron deficiency, defined as low serum iron \ 400 µg/dl. * able and willing to provide informed consent * willing to comply with oral supplementation and study follow-up exclusion criteria: * severe anemia, defined as hemoglobin (hb) \<8 g/dl, requiring urgent intervention * known malabsorption syndromes (e.g., celiac disease, ibd) * active bleeding or blood transfusion within the past 3 months * pregnancy or lactation * use of iron supplements within the past 4 weeks * known allergy or intolerance to oral iron formulations
comparison of the efficiency of intra-uterine insemination and in vitro fertilization in women over 37 years

Conditions: Infertilities

Summary: as age increases the chances for a woman to become pregnant decrease as well spontaneously as through assisted reproductive technologies (art). for the treatment of unexplained infertilities two techniques can be used: intra-uterine insemination (iui) and in vitro fertilization (ivf). the aim of the present study is to compare the efficiency in term of delivery rate of iui and ivf in couples in whom the female age is over 37 years.

iui can be used to treat infertility when tubes are normal, with no severe endometriosis and enough motile spermatozoa can be inseminated. in these cases iui are usually performed (4 to 6 attempts) and ivf only in case of iui failure. indeed if the pregnancy rate per attempt is higher with ivf, iui can be performed more frequently (6 times a year vs. 2 for ivf) so that the pregnancy rates after one year of treatment are close. when female age is over 37 years, some art centers prefer to perform directly ivf, since chances of pregnancy decreases with time. however there is no argument in the literature in favor as well as in disfavor for such an attitude. indeed the delivery rates after one year treatment with iui or ivf are not known in this population. therefore we propose a multicentric randomized controlled trial comparing iui and ivf in women over 37 with unexplained infertility. couples will be randomly allocated to iui or ivf during one year. in case of absence of pregnancy after 4 iui, couples will be treated by ivf. art attempts will be performed according to usual procedures of each center. the follow-up will be ended either at the end of the first year of treatment if no pregnancy is obtained or at the time of delivery if a pregnancy is obtained. all data of attempts (demographics data, type and doses of treatment, adverse effects, outcome, number and health state of newborns....) will be recorded.

Eligibility criteria:
inclusion criteria: * female age between 37 and 42 years at the time of inclusion * infertility duration ≥ 12 months * normal tubes * no severe endometriosis * at least 1.5 106 motile spermatozoa to be inseminated * no previous art attempt exclusion criteria: * tubal abnormalities * severe endometriosis * less than 1.5 106 motile spermatozoa to be inseminated * use of frozen sperm * presence of anti-spermatozoa antibodies

Keywords: infertility female age intra-uterine insemination in vitro fecundation assisted reproductive technology center
study to assess efficacy and safety of inecalcitol in imatinib-treated residual chronic myeloid leukaemia: inim study

Conditions: CML, Chronic Phase

Summary: to assess the efficacy of inecalcitol in combination with imatinib in cml patients with molecular residual disease on imatinib monotherapy.

to determine: * duration of response * progression free survival * proportion of responders 2 years after discontinuation of inecalcitol * duration of response after discontinuation of inecalcitol and imatinib * bone remodelling effect * safety of inecalcitol in combination with imatinib * quality of life

Eligibility criteria:
inclusion criteria: * men or women aged of at least 18 years at the time of informed consent signature; * patients have signed written informed consent; * ecog performance status \< 2; * patients with philadelphia chromosome positive chronic phase cml and m bcr-abl transcript positivity (e13a2 or e14a2); * treatment with imatinib for more than 2 years (a history of treatment with interferon is tolerated); * patient in complete cytogenetic response with bcr-abl/abl status between 0.1% international scale (is) and 0.01% is and no bcr-abl checkpoint in the last six months better than molecular response mr4 ( i.e. bcr-abl ratio \< 0.01% is); * women of child bearing potential have a negative pregnancy test prior to first dose and agree to practice effective contraception during the study; * fertile men agree to practice effective contraception during the study; * patients agree to comply with the study requirements and agree to come to the clinic for required study visits; * patients agree to follow medication restrictions during the study; exclusion criteria: * expression of unusual bcr-abl transcripts (other than e13a2 or e14a2); * pregnant or lactating women; * participating in another clinical trial with any investigative drug within 30 days prior to study enrolment(except for optim imatinib); * treatment with interferon within the last 24 months; * imatinib dose modification within the last 3 months; * prior history of haematopoietic stem cell transplantation; * impaired renal function with creatinine clearance \< 30 ml/min/1.73m² according to the mdrd formula; * hypercalcemia (corrected with albuminemia); * history of diseases known to be associated with calcium disorders: ongoing hyperparathyroidism, sarcoidosis....; * presence or history of symptomatic kidney stones in the last 5 years; * current use of drugs known to influence serum calcium (such as thiazide diuretics, teriparatide, calcitonin and multivitamin supplements containing \> 400 iu of vitamin d or calcium); * current use of digitalis; * current use of drugs which could influence bioavailability of inecalcitol (such as magnesium-containing antacids, bile-resin binders); * patients with a chronic condition which is not well controlled that, according to the investigator, would interfere with the completion of the study; * use of any other experimental drug, therapy or vitamin d supplementation within 30 days of first inecalcitol administration; * patients with a mental deficiency preventing proper understanding of trial protocol requirements;
effects of preoperative frailty on postoperative recovery

Conditions: Frailty

Summary: this study aims to evaluate frailty using short physical performance battery (sppb) before surgery and find out how frailty affects short-term postoperative recovery after surgery using quality of recovery-15 (qor-15) questionnaire in patients undergoing minimally invasive distal gastrectomy for early gastric cancer.

as the elderly population increases, the evaluation and management of preoperative frailty is becoming important. in patients with frailty, exposure to external stress, such as surgery, can reduce physical function, increase postoperative complication, and raise the risk of death. this study aims to evaluate frailty using an automated device performing sppb (andantefit) and find out how frailty affects postoperative recovery.

Eligibility criteria:
inclusion criteria: * patients over 70 years of age, undergoing minimal invasive (laparoscopic, robot-assisted) distal gastrectomy for early gastric cancer, who can assess short-term postoperative recovery exclusion criteria: * patients who have a difficulty in communication * patients who have a major medical or mental disease that can affect treatment outcome * patients unsuitable for this clinical trail on the opinion of researcher
the impact of incorporating an exergame activity application in a treatment regimen for overweight children

Conditions: Body Mass Index; Blood; Sugar, High; Lipid Disorder; Body Image

Summary: 80 children aged 5-13, bmi≥85%, will be recruited to a program for the treatment of overweight children.the intervention group will use the app "just dance now" and the control group will be exposed to the usual program without the app. measurements will be performed at the beginning of the program, the end and 3 months after completion of the intervention.

80 children aged 5-13, bmi≥85%, will be recruited to the five-month program, at two centers for the treatment of overweight children. the intervention group will use the app "just dance now" and part of a weekly exercise session will be dedicated to a group app activity. the control group will be exposed to the usual program without the app. measurements of bmi, blood sugar and lipid profiles, as well as physical examination, and questionnaires regarding attitude and response to physical activity will be performed at the beginning of the program, the end and 3 months after completion of the intervention. participation in the sessions will be documented and home activity recorded using a weekly log. anova two-way repeated measures will be used to assess improvements in outcome measures.

Eligibility criteria:
inclusion criteria: * children aged 5-13 from the center for the treatment of overweight children in the macabi health organization * bmi≥85%. exclusion criteria: * children with physical disabilities, that don't allow participation in physical activity during the study. * children who don't own a mobile phone or don't have an access to a computer to activate the app for one hour a day. * bmi\<85%

Keywords: exergame cellular apps smartphone overweight obesity children physical activity fitness motivation bmi
implementing a randomized control trial to test the expanded web-based decision aid

Conditions: Cholangiocarcinoma; Colorectal Cancer; Multiple Myeloma

Summary: the overall goal of the randomized control trial (rct) will be to evaluate the efficacy of modifications to a web-based tool for patient decision-making regarding return of genomic results that will more closely focus on rare cancers. participants will be given access to a web-based decision aid (or a standard control) that guides participants in making decisions about what type of genomic results they would like to receive from testing performed in the pe-cgs study (nct06340646).


Eligibility criteria:
eligibility criteria: * enrolled in the wu-pe-cgs study (irb#202106129); that eligibility entails: * diagnosis of cholangiocarcinoma * diagnosis of multiple myeloma, must be african american * diagnosis of colorectal cancer, must be african american and age 65 or older at time of diagnosis * at least 18 years old. * able to understand an irb-approved informed consent document and agree to participation * have access to a personal computer, tablet or mobile device

Keywords: genetic testing decision aid participant engagement
a study of the effects of topical capsaicin in the treatment of provoked vestibulodynia

Conditions: Vestibulodynia

Summary: this study aims to assess the pain on contact in provoked vestibulodynia, measured with visual analogic scale at week 0/week 2/week 6/week 12 after applying a patch of capsaicin.


Eligibility criteria:
inclusion criteria: * provoked vulvodynia, rated b2a according to 2003 international society for the study of vulvovaginal disease (issvd) classification * pain ≥ 4 on visual analogic scale (vas) * subject refractory to at least 2 conventional treatments (tricyclic antidepressants, anticonvulsants at analgesic doses , biofeedback physical therapy, psychological assessment in a context of chronic pain) or to botulinum toxin a * if a former treatment with botulinum toxin a was performed: patient must be in treatment failure (= no decrease over 50% of the pain 3 months after initiation of the treatment) * negative screening test results * menopause, surgically sterilized women or women using effective contraceptive method * good understanding and predictable adherence to the protocol * beneficiary/affiliated to french social security/social healthcare * signed informed consent form exclusion criteria: * predictable poor adherence * pregnant or breastfeeding women * diabetes mellitus type 1 or type 2 * major mental disorders * underlying etiology such as chronic vulvar disease * initial vulvar erythema * vulnerable subjects (particularly adults under guardianship) * ongoing medical treatment with tricyclic antidepressants or anticonvulsants at analgesic doses subject refractory to conventional treatments (tricyclic antidepressants and benzodiazepines doses analgesics, physiotherapy type of biofeedback) good understanding and predictable adherence to the protocol beneficiary/affiliated to french social security/social healthcare signed informed consent form

Keywords: capsaicin pain improvement provoked vulvodynia
dasiglucagon in the treatment of postprandial hypoglycaemia after roux-en-y gastric bypass

Conditions: Hyperinsulinemic Hypoglycemia; Postprandial Hypoglycemia

Summary: the aim of this study is investigating the effect of a novel glucagon analogue administration in gastric bypass operated individuals, who are reactive hypoglycemic.

the roux-en-y gastric bypass (rygb) has major health-promoting effects - reversing type-2-diabetes, improving dyslipidemia and inducing robust weight loss. however, several rygb-individuals, post surgery, suffers from dumping syndrome and postprandial hyperinsulinemic hypoglycemia (phh) due to the anatomical rearrangement of the gastro-intestinal system. dasiglugaon (also known as (zp4207) has shown great pharmacokinetic- and dynamic effects, compared to other glucagon analogues on the market, when administrated to hypoglycemic type-1-diabetics. therefore we aim to examine the effects of two different doses of dasiglucagon on the postprandial nadir plasma glucose concentration in rygb-operated individuals suffering from phh by use of a mixed meal test (mmt). the study is designed as a double-blinded, randomised, 3-period, 3-treatment, crossover study comprising 3 separate treatment days in which participants will undergo an mmt along with one of the following double-blinded interventions: 1. subcutaneous (sc) placebo (saline) injection 2. sc injection with 80 μg dasiglucagon 3. sc injection with 200 μg dasiglucagon

Eligibility criteria:
inclusion criteria: * documented postprandial hypoglycaemia (\<3.9 mmol/l) by 6-day cgm or during a mmt * documented plasma glucose concentration excursions \>5.0 mmol/l by 6-day cgm or a mmt * haemoglobin levels for women \>7.3 mmol/l and for men \>8.3 mmol/l * ferritin \>10 μg/l * cobalamin \>150 pmol/l * fasting plasma glucose concentration within the range of 4.0-6.0 mmol/l ckn-dasi-rygb protocol version 1.0 6 * normal electrocardiogram (ecg) * negative urine human chorionic gonadotropin (hcg) (for fertile women) exclusion criteria: * treatment with medication(s) affecting insulin secretion or any antidiabetic drugs * treatment with antipsychotics * current participation in another clinical trial with administration of investigational drug. * previous exposure to dasiglucagon (otherwise known as zp4207) * history of liver disease that is expected to interfere with the anti-hypoglycaemic action of glucagon (e.g. liver failure or cirrhosis). * pregnancy * breastfeeding * any factors that, in the opinion of the site principal investigator or clinical protocol chair, would interfere with the safe completion of the study, including medical conditions that may require hospitalization during the trial or allergy to the ingredients in the study drug.